Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NuVasive
ClinicalTrials.gov Identifier:
NCT00948532
First received: July 16, 2009
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

This is a prospective, non-randomized multi-center study to compare the use of Osteocel® Plus in subjects who receive XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two levels. These subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus during their XLIF operation. Subjects will be followed for 24-months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively, and to determine the mean time to fusion. This data will be compared to published and/or retrospective data for autograft, synthetic ceramics and Bone Morphogenetic Protein (BMP).


Condition Intervention
Degenerative Disc Disease
Back Pain
Biological: biologic, Osteocel Plus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®): Evaluation of Radiographic and Patient Outcomes

Resource links provided by NLM:


Further study details as provided by NuVasive:

Primary Outcome Measures:
  • The proportion of subjects with radiographically apparent fusion. [ Time Frame: 6-months, 12-months and 24-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The evaluation of angular displacement on flexion/extension films. [ Time Frame: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month ] [ Designated as safety issue: No ]
  • The evaluation of bridging bone on CT. [ Time Frame: 6-month, 12-month ] [ Designated as safety issue: No ]
  • Preservation of interbody height over time. [ Time Frame: All post-operative follow-up visits: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month ] [ Designated as safety issue: No ]
  • The rate of complications attributable to the use of Osteocel Plus requiring intervention. [ Time Frame: All study follow-up visits: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month ] [ Designated as safety issue: No ]
  • The change in subject self-reported pain ratings (VAS scores). [ Time Frame: from baseline through post-operation follow-up (visits at post-op, 6-week, 3-month, 6-month, 12-month and 24-months) ] [ Designated as safety issue: No ]
  • The change in Oswestry Disability Index scores. [ Time Frame: from baseline through post-operation follow-up (visits at post-op, 6-week, 3-month, 6-month, 12-month and 24-months) ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: March 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: biologic, Osteocel Plus
    Osteocel® Plus
    Other Name: Osteocel® Plus
Detailed Description:

Osteocel Plus is an allograft cellular bone matrix containing native mesenchymal stem cells (MSCs) which is intended to mimic the biologic performance of autograft without the morbidity associated with the autograft harvest. Mesenchymal stem cells, like those found in Osteocel Plus, are naturally occurring in the body and can differentiate into a variety of tissue types, depending on the local environment. Once implanted, MSCs can differentiate into osteoblasts, which produce new bone matrix. MSCs also naturally secrete bone-inducing growth factors that signal the patient's endogenous cells to migrate and participate in the bone formation process. Osteocel Plus is different from other orthobiologic products such as DBM and allograft cancellous bone because it contains living stem cells, which provide osteogenic potential. The cells include mesenchymal stem cells from an adult human donor; they are not from an embryonic source.

This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel in an XLIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells in conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will be comparable to published data for autograft. The Osteocel product family has already been used in approximately 15,000 cases worldwide.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Existing clinic patients

Criteria

Inclusion Criteria:

  1. Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless clinically indicated earlier
  2. Indicated for interbody fusion of one or two contiguous lumbar segments (L1 to L5)
  3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
  4. 18-80 years of age at the date of written informed consent
  5. Able to undergo surgery based on physical exam, medical history and surgeon judgment
  6. Expected to survive at least 2 years beyond surgery
  7. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
  8. Signed and dated Informed Consent Form

Exclusion Criteria:

  1. Patient has a mental or physical condition that would limit the ability to comply with study requirements
  2. Lumbar spine abnormality requiring treatment at more than two levels
  3. Systemic or local infection; active or latent
  4. Previous failed fusion at the operative level
  5. Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
  6. Undergoing chemotherapy or radiation treatment, or chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
  7. Pregnant, or plans to become pregnant during the study
  8. Subject is a prisoner
  9. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended)
  10. A significant general illness (e.g., HIV, active metastatic cancer of any type) is present; subject is immunocompromised or is being treated with immunosuppressive agents
  11. Participating in another clinical study that would confound study data
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948532

Locations
United States, California
Shiley Center for Orthopaedic, Scripps Green Hospital
La Jolla, California, United States, 92037
United States, Florida
Broward Spine Institute
Hollywood, Florida, United States, 33021
South Florida Spine Institute, Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Southeastern Spine Center, Doctors Hospital of Sarasota
Sarasota, Florida, United States, 34232
USF, Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
Pinnacle Orthopaedics, Wellstone Kennestone Hospital
Marietta, Georgia, United States, 30060
United States, Illinois
The Spine Center of DuPage Medical Group, Edward Hospital
Naperville, Illinois, United States, 60540
United States, Indiana
Indiana Center for Neurosurgery
Indianapolis, Indiana, United States, 46219
United States, Missouri
Columbia Orthopaedic Group, Boone Hospital Center
Columbia, Missouri, United States, 65205
Spine Midwest, St. Mary's Health Center
Jefferson City, Missouri, United States, 65101
United States, Nevada
Western Regional Center for Brain & Spine Surgery, Surgery Center of S. Nevada
Las Vegas, Nevada, United States, 89109
United States, New York
Buffalo Spine Surgery, Kenmore Mercy
Lockport, New York, United States, 14094
United States, North Carolina
Duke University Medical Center
Chapel Hill, North Carolina, United States, 27710
Sponsors and Collaborators
NuVasive
Investigators
Study Director: Kelli Howell, MS NuVasive
  More Information

Additional Information:
No publications provided

Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT00948532     History of Changes
Other Study ID Numbers: NUVA.OC.0801
Study First Received: July 16, 2009
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by NuVasive:
degenerative disc disease
lumbar spine
XLIF
Degenerative conditions

Additional relevant MeSH terms:
Back Pain
Spinal Diseases
Intervertebral Disk Degeneration
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 24, 2014